AZ, Ironwood in China Drug Pact

AstraZeneca and Ironwood Pharmaceuticals have entered an agreement to co-develop and co-commercialize Ironwood’s linaclotide in China. Linaclotide, an aguanylate cyclase-C (GC-C) agonist, received FDA approval in August. Ironwood has also filed a clinical trial application with the SFDA in China for a Phase III trial to assess safety and efficacy of linaclotide in irritable bowel syndrome with constipation (IBS-C).

The two companies are jointly responsible for strategic oversight of the development and commercialization, and AZ will have primary responsibility for the local operational execution. Ironwood will receive an upfront payment of $25 million and AZ will initially carry 55% of profits and losses until a certain milestone is achieved, and will then shift to a 50/50 split. Ironwood will also be eligible for $125 million in additional commercial milestone payments based on certain sales targets.

“China is one of the fastest growing prescription medicines markets in the world and linaclotide represents a valuable opportunity to meet the needs of local patients by providing an innovative new treatment option,” said Mark Mallon, regional vice president for Asia Pacific and president, AstraZeneca China. “We are pleased to be partnering with Ironwood for linaclotide in China, which capitalizes on our leadership in the gastrointestinal sector in the emerging markets.”

In addition, the companies entered an agreement under which Ironwood will use its sales force of approximately 160 clinical sales specialists to promote AstraZeneca’s Nexium in the U.S.